Stela Model BJ44 and BJ45 Pacing Leads

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K963738 ↗

FDA Product Code

DTB

Device Class

Class III

Regulation

21 CFR Part 870.3680

Advisory Committee

Cardiovascular

FDA Decision

PT

• Pacing Lead #PMA F 860

  Class III

  FDA 510(k) K830457 Active Cleared 17 Mar 1983

• Opus Pulse Generators Models 2001, 2003, and 2004

  Class III

  FDA 510(k) K882474 Active Cleared 12 Sep 1988

• Lead Models MUM 1260, MUM 1290

  Class III

  FDA 510(k) K790386 Active Cleared 3 Apr 1979

• Focus J81F, J83F, J41F, J43F Pacing Leads

  Class III

  FDA 510(k) K896742 Active Cleared 17 Jul 1990

• Focus T41, T41F, T43, T43F, T44F

  Class III

  FDA 510(k) K904255 Active Cleared 18 Jan 1991

• Opus Pacemakers (Models 4001, 4003, 4004, 4023, 4024)

  Class III

  FDA 510(k) K952364 Active Cleared 1 Sep 1995

See all devices from Ela Medical, Inc. →

• Are the Stela Model BJ44 and BJ45 Pacing Leads reusable or designed for single-use, and how should they be handled after opening?

  The Stela Model BJ44 and BJ45 Pacing Leads are explicitly designed for single-use only and are supplied sterile. After opening the packaging, they must be used immediately and discarded to maintain sterility and prevent contamination. Reuse is not recommended or supported by the manufacturer.

• What types of pacemaker systems are the BJ44 and BJ45 leads compatible with, and how are they differentiated from each other?

  The BJ44 and BJ45 leads are both classified as Permanent Pacemaker Electrodes and are intended for implantation in the cardiovascular system to deliver electrical stimulation for cardiac rhythm regulation. While the manufacturer does not specify differences in their technical specifications or indications in the provided data, they are tracked under the same Permanent Pacemaker Electrode (870.3680) category. Compatibility with specific pacemaker systems would depend on the manufacturer’s broader product line and system requirements, which are not detailed here.

• How should the Stela Model BJ44 and BJ45 Pacing Leads be stored before use, and what precautions should be taken?

  The leads are supplied sterile, so storage should follow standard sterile medical device protocols. They should be kept in their original, unopened packaging in a clean, dry environment, protected from physical damage, extreme temperatures, and direct sunlight. Avoid exposure to moisture or contaminants, as this could compromise sterility or integrity. The manufacturer does not specify shelf-life details, so adherence to the expiration date on the packaging is critical.

• What regulatory pathway was followed for FDA clearance of the Stela Model BJ44 and BJ45 Pacing Leads, and what does this mean for clinicians?

  The Stela Model BJ44 and BJ45 Pacing Leads were cleared through the FDA 510(k) process (K963738), classified as Class III devices under the Permanent Pacemaker Electrode (DTB) category. This pathway confirms they meet FDA standards for safety and effectiveness as Permanent Pacemaker Electrodes, intended for implantation in the cardiovascular system. Clinicians can rely on this clearance as evidence of regulatory scrutiny, though individual patient suitability should always be assessed by a qualified physician.